What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

American Guidelines

Clinical guidelines, regulatory resources, and compliance tools

221 resources

All American Guidelines 221 Cardiology & Vascular 19 Dermatology & Venereology 7 Endocrinology, Diabetes & Metabolism 20 Eye, ENT & Neurosensory 7 Gastroenterology & Hepatology 47 Imaging & Radiology 5 Infectious Diseases & Microbiology 13 Internal Medicine & Emergency 4 Medical Technology & Engineering Neurology & Neurosurgery 12 Oncology & Haematology 33 Paediatrics 6 Public Health & Primary Care 8 Rehabilitation & Geriatrics 4 Respiratory & Intensive Care 8 Rheumatology & Immunology 11 Surgery & Orthopaedics 5 Umbrella & Cross-Cutting Women's Health & Obstetrics 12

221 resources

AAD Guidelines for Management of Basal Cell Carcinoma

Clinical Guideline 2018 American Guidelines Dermatology & Venereology

Clinical Guideline by AAD in Dermatology & Venereology (2018).

American Guidelines

AAD Guidelines for Management of Basal Cell Carcinoma

AAD Guidelines for Management of Alopecia Areata

AAD Guidelines for Management of Atopic Dermatitis

AAD Guidelines for Management of Acne Vulgaris

IDSA/SHEA Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship

IDSA HIV Primary Care Guideline

IDSA/ATS Community-Acquired Pneumonia Guidelines

IDSA Guidelines on Management of Urinary Tract Infections

IDSA Guidelines for Diagnosis and Treatment of Aspergillosis

IDSA Guidelines for Management of Skin and Soft Tissue Infections

IDSA Guideline for Management of Prosthetic Joint Infection

IDSA Guidelines for Diagnosis and Management of Candidiasis

IDSA Clinical Practice Guidelines for Clostridium difficile Infection

IDSA Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis

IDSA Clinical Practice Guideline for Treatment of Drug-Susceptible Tuberculosis

IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis

IDSA Clinical Practice Guideline for Treatment of Coccidioidomycosis

ATS/ERS/JRS/ALAT Guideline for Diagnosis of Idiopathic Pulmonary Fibrosis

ATS/IDSA Practice Guidelines for Adults With Hospital-acquired and Ventilator-associated Pneumonia

ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis

ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Resistant Tuberculosis

ATS/ERS Clinical Practice Guideline: Definition, Evaluation, and Treatment of Severe Asthma

ATS Clinical Practice Guideline: Management of Obstructive Sleep Apnea in Adults

ATS Guidelines for Pulmonary Rehabilitation in Adults

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